Senior Director Clinical Development

BioPhase; United States; On-site; USD 260,000 - 420,000; Full time

Job summary

BioPhase in the United States is seeking a Senior Director, Clinical Development (MD) to lead medical strategy and execution across ophthalmology programs from early to late-stage development.

You will oversee trial design, safety monitoring, regulatory submissions, and cross-functional collaboration while ensuring regulatory compliance, timely delivery, and high-quality outcomes.

Qualifications

• MD with 8+ years of industry clinical development experience.
• Demonstrated leadership in ophthalmology disease trials.
• Strong background in drug development, regulatory strategy, and clinical operations.
• Proven ability to lead cross-functional teams in a fast-paced environment.
• Experience with global regulatory interactions (FDA/EMA preferred).

Responsibilities

• Lead and execute clinical development strategies across multiple programs
• Provide medical oversight for trial design, conduct, and data interpretation
• Serve as medical lead for regulatory interactions and key submissions (e.g., INDs, briefing packages, study reports)
• Ensure compliance with GCP, ICH, and applicable regulatory requirements
• Partner cross-functionally to deliver studies on time and within budget
• Engage with external experts, investigators, and advisors as needed

Skills

Clinical development

Regulatory strategy

GCP / ICH

Cross-functional leadership

Regulatory filings

Ophthalmology trials

Education

MD

Job description

• Approximately 25% travel may be required

Senior Director, Clinical Development (MD)

We are seeking an experienced physician leader to drive clinical strategy and execution across a portfolio of programs. This individual will provide medical and scientific leadership from early-through late-stage development, ensuring strong study design, regulatory alignment, and high-quality clinical outcomes.The role includes oversight of clinical trial strategy, protocol development, safety monitoring, and benefit–risk assessment, while serving as the primary medical expert for assigned programs.

Key Responsibilities:

• Lead and execute clinical development strategies across multiple programs
• Provide medical oversight for trial design, conduct, and data interpretation
• Serve as medical lead for regulatory interactions and key submissions (e.g., INDs, briefing packages, study reports)
• Ensure compliance with GCP, ICH, and applicable regulatory requirements
• Partner cross-functionally to deliver studies on time and within budget
• Engage with external experts, investigators, and advisors as needed

Qualifications:

• MD with 8+ years of industry clinical development experience
• Demonstrated leadership in ophthalmology disease trials
• Strong background in drug development, regulatory strategy, and clinical operations
• Proven ability to lead cross-functional teams in a fast-paced environment
• Experience with global regulatory interactions (FDA/EMA preferred)